Knoebl 2020-12-09 Public Declaration of Interests and Confidentiality Undertaking of European Medicines Agency (EMA), Scientific Committee members and experts Public declaration of interests I, Paul Knoebl Organisation/Company: Medical University of Vienna Country: Austria do hereby declare on my honour that, to the best of my knowledge, the only direct or indirect interests I have in the pharmaceutical industry are those listed below: 2.1 Employment No interest declared 2.2 Consultancy Period Company Products Therapeutic Indication 01/2009-(current) Novo Nordisk acquired hemophilia, congenital hemophilia, rare bleeding disorders 01/2012-02/2019 Baxalta (now Shire) thrombotic thrombocytopenic purpura purpura fulminans acquired hemophilia 01/2012-01/2016 Alexion thrombotic microangiopathy 03/2010-07/2018 Ablynx thrombotic microangiopathy 07/2018-(current) Sanofi Genzyme thrombotic microangiopathy 02/2019-(current) Takeda thrombotic microangiopathy Acquired hemophilia 2.3 Strategic advisory role No interest declared 2.4 Financial interests Classified as public by the European Medicines Agency DOI Form Version-number: 4 Knoebl 2020-12-09 2 No interest declared 2.5 Principal investigator Period Company Products Therapeutic Indication 01/2013-(current) Baxalta, then Shire, now Takeda BAX930 Upshaw Schulman Syndrome 01/2013-(current) Novo Nordisc Concizumab Hemophilia 09/2010-04/2014 Gilead Ambisome fungal infections 09/2010-04/2014 MSD Posaconazol fungal infections 03/2010-(current) Ablynx caplacizumab thrombotic thrombocytopenic purpura 04/2010-01/2012 MSD V212 Herpes Zoster vaccination 01/2007-01/2010 Archemix ARC1779 Thrombotic thrombocytopenic purpura 01/2016-(current) Alexion ALXN1210 thrombotic microangiopathy 01/2020-(current) Argenx Efgartigimod Autoimmune Thrombocytopenia 2.6 Investigator No Interest Declared 2.7 Grant / Funding to organisation /institution Company Subject Matter Novo Nordisk Support for establishing the national acquired hemophilia A registry Sanofi Support for establishing the national thrombotic microangiopathy registry 2.8 Close family member interest No interest declared 2.9 Repurposing of a medicinal product Period Products Therapeutic Indication Involvement in the repurposing 04/2018-(current) emicizumab acquired hemophilia A Involvement in the repurposing of the medicinal product where my organisation is acting as the champion of the repurposing Classified as public by the European Medicines Agency DOI Form Version-number: 4 Knoebl 2020-12-09 3 2.10 Any other interests or facts Member of the Ethics Commitee of the Medical University of Vienna 2.11 CAT member or alternate No interest declared CONFIDENTIALITY UNDERTAKING In view of the following definitions: "EMA Activities" encompass any meeting (including meeting preparation and follow-up, associated discussion or any other related activity) of the European Medicines Agency's Management Board, Committees, Working Parties, Expert Groups, or any other such meeting; work as an expert on assessments; work as an expert on guidance development. "Confidential Information" means all information, facts, data and any other matters of which I acquire knowledge, either directly or indirectly, as a result of my EMA Activities. "Confidential Documents" mean all drafts, preparatory information, documents and any other material, together with any information contained therein, to which I have access, either directly or indirectly, as a result of my participation in EMA Activities. Furthermore, any records or notes made by me relating to Confidential Information or Confidential Documents shall be treated as Confidential Documents. I understand that I may be invited to participate either directly or indirectly in certain EMA activities and hereby undertake: • To treat all Confidential Information and Confidential Documents under conditions of strict confidentiality as long as the information or document has not been made public/is not in the public domain. • Not to disclose (or authorise any other person to disclose) in any way to any third party any Confidential Information or Confidential Document. • Not to use (or authorise any other person to use) any Confidential Information or Confidential Document other than for the purposes of my work in connection with EMA activities. • To dispose of Confidential Documents as confidential material as soon as I have no further use for them. • When expressing views to clearly indicate that the views are my own if acting in my own capacity or those of the EMA, Committee, Working Party, Expert Group or other group if acting on behalf that group. • Not to disclose any commercially confidential information. This undertaking shall not be limited in time, but shall not apply to any document or information that I can reasonably prove was known to me before the date of this undertaking or which becomes public knowledge other than as a result of a breach of any of the above undertakings. I confirm the information declared on this form is accurate to the best of my knowledge and I acknowledge that my information will be stored electronically and published on the EMA website. Full Name: Paul Knoebl Date: 2020-12-09 For Definitions of activities etc, refer to Policy on Handling of competing interests / Electronic DOI template Classified as public by the European Medicines Agency DOI Form Version-number: 4.
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